Informed Consent Template

You may use a WCG or sponsor provided informed consent form template provided it is edited to insert institutionally required local language.   

First, WCG should ensure all of the following are part of your informed consent:

  • All consents must include a UF logo in the upper left or upper right of the first page of the consent.

  • A heading indicating that the document is an Informed Consent Form and Authorization to Collect, Use, and Disclose Protected Health Information (PHI).
  • Include a valid HIPAA authorization.
  • A signature line documenting consent and authorization.
  • IRB contact for subjects: “If you have questions about your rights as a research subject, please call the University of Florida Institutional Review Board (IRB) office at (352) 273-9600.

Second, as part of UF’s process of submitting research to WCG, you must complete the UF Cover Letter form.  Once submitted, you will receive an email that is used to include with your submission to WCG.  That email may include additional language that needs to be included in your informed consent forms, so please review the email cover sheet carefully.  It is a Principal Investigator’s responsibility to fill out the UF Cover Letter form accurately to ensure compliance with regulations and institutional policies.

Third, researchers must insert one of UF’s four approved “cost to study subjects” templates into the consent form. NOTE:  you must have both WCG IRB approval and CRH/ORA activation before you can enroll any study subjects.  CRH/ORA will verify that the cost language in the consent is appropriate based on the contract/billing.  If the language isn’t appropriate, researchers will be directed to submit a revision to insert the appropriate language, the approval for which must be verified by CRH/ORA before they issue their activation.  A workflow diagram of this process is is available at: https://research.ufl.edu/wp-content/uploads/Visio-Consent-cost-workflow.pdf 

Any deviations from the local context language (except for the language provided by UF ancillaries) needs to be approved by Ivana Simic (isimic@ufl.edu).